MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number ASKU

Device Problems Loose or Intermittent Connection (1371); Protective Measures Problem (3015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/30/2024

Event Type  malfunction  

Manufacturer Narrative

G1 manufacturing facility - this device was manufactured at one of the two following manufacturing sites: baxter healthcare - mountain home 1900 n highway 201 mountain home, ar 72653 united states.Baxter healthcare - dominican republic carretera sanchez km 18.5, parque industrial itabo, piisa haina, san cristobal 91000 dominican republic.An alarm indicative of a potential malfunction of the disposable cassette was reported.The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.However, a loose connection was reported between the supply line of the homechoice cassette and the supply bag, which is known to cause this alarm.The cause of the loose connection could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a homechoice (hc) device experienced a system error 2240 (air in line/set) alarm.The patient was connected at the time of the alarm.This occurred during dwell one of four of peritoneal dialysis therapy.During troubleshooting, it was reported that there was a loose connection between the supply line with the blue clamp of the homechoice cassette and the supply bag that led to this alarm.Renal therapy services (rts) assisted the patient with clearing the alarm and in removing the supplies.Proper procedures per the user manual were reviewed with the patient.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: NI
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION; see h10; see h10; see h10
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 19183018
• MDR Text Key: 341058553
• Report Number: 1416980-2024-01899
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/30/2024
• Initial Date FDA Received: 04/25/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HOMECHOICE (HC) CLARIA DEVICE; UNSPECIFIED PD SOLUTION